Perrigo Company has acquired rights to Novel Laboratories’ pending ANDA for HalfLytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed release tablets), indicated for the cleansing of the colon as a preparation for colonoscopy in adults. Annual sales for the Braintree Laboratories brand were approximately US$ 80 million according to Wolters Kluwer.

Novel Laboratories believes it was first to file an ANDA containing a Paragraph IV Certification with the US Food & Drug Administration, and therefore the product is expected to be approved with 180 days of generic exclusivity. The brand marketing exclusivity ends on September, 24, 2010. The company has not been sued. Under terms of the Perrigo/Novel agreement, Novel will manufacture the product exclusively for Perrigo.

Perrigo’s chairman and CEO Joseph C Papa concluded, “This acquisition is another example of Perrigo’s ongoing commitment to solidify our leadership position in the generic extended topical space, and to deliver quality, affordable healthcare products to retailers and consumers. Novel has a strong track record of bringing high-value first generic products into the market, and we look forward to our
collaboration.”

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products.